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Virus Therapy
PVSRIPO for Brain Tumor
Phase 2
Waitlist Available
Led By Dina Randazzo, DO
Research Sponsored by Istari Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Presence of recurrent tumor confirmed by histopathological analysis at the time of biopsy
Patients must have a recurrent supratentorial WHO grade IV malignant glioma based on imaging studies with measurable disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 and 36 months post-infusion and through study completion.
Awards & highlights
Study Summary
This trial is testing a new virus to see if it can kill cancer cells in people with a certain type of brain tumor.
Who is the study for?
Adults over 18 with recurrent WHO grade IV malignant glioma (brain tumor), measurable disease, and good performance status. They must have normal blood counts, organ function, and no severe co-morbidities. Not for pregnant women or those with a history of poliovirus complications, recent other cancer treatments, or certain autoimmune diseases.Check my eligibility
What is being tested?
The trial is testing PVSRIPO in patients with recurrent malignant glioma to see if it can help treat this type of brain tumor. It's a phase 2 study which means they're looking at how effective the treatment is and gathering more information on its safety.See study design
What are the potential side effects?
While specific side effects are not listed here, typical ones from similar treatments may include flu-like symptoms such as fever and chills, fatigue, headache, nausea or vomiting. There could also be risks associated with inflammation in the brain due to the virus used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My biopsy confirmed I have a recurring tumor.
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My brain tumor has returned, is aggressive, and can be measured.
Select...
I am 18 years old or older.
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I am mostly able to care for myself.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 and 36 months post-infusion and through study completion.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 and 36 months post-infusion and through study completion.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Duration of Objective Radiographic Response
Objective Radiographic Response Rate
Secondary outcome measures
Disease Control Rate Following PVSRIPO Infusion
Landmark Survival
Overall Survival
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Polio/Rhinovirus Recombinant (PVSRIPO)Experimental Treatment1 Intervention
Polio/Rhinovirus Recombinant (PVSRIPO)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PVSRIPO
2018
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Duke UniversityOTHER
2,358 Previous Clinical Trials
3,419,947 Total Patients Enrolled
Istari Oncology, Inc.Lead Sponsor
12 Previous Clinical Trials
297 Total Patients Enrolled
Dina Randazzo, DOPrincipal InvestigatorDuke University
3 Previous Clinical Trials
142 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am at risk of a severe brain condition due to pressure increase.I am not pregnant or breastfeeding.I have tumors or signs of cancer visible on scans.I have had neurological issues from a PV infection before.I or my partner meet the study's criteria for female participants.I am a sexually active male and meet the study's safety criteria.I haven't had certain cancer treatments just before starting the study drug.I am still experiencing side effects from my previous cancer treatments.My biopsy confirmed I have a recurring tumor.I have had immunotherapy and recovered from its side effects before starting the study drug.I am 18 years old or older.I have taken more than 4 mg of dexamethasone daily in the last 2 weeks.I have a known history of agammaglobulinemia.I am currently not receiving treatment for another type of cancer.My muscle weakness is getting worse because of steroid use.I am mostly able to care for myself.My brain tumor has returned, is aggressive, and can be measured.I received a booster shot with IPOL vaccine between 1 week and 6 weeks ago.I had brain radiation therapy less than 12 weeks ago.I haven't taken systemic immunomodulatory drugs for my autoimmune disease in the last 3 months.I haven't finished all recommended treatments like surgery or radiation.
Research Study Groups:
This trial has the following groups:- Group 1: Polio/Rhinovirus Recombinant (PVSRIPO)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available slots for participants in this experiment?
"The clinical trial detailed on clinicaltrials.gov is not currently enrolling patients; however, it was last updated on 6/28/2022 and may recruit in the future. There are 365 other trials that are presently recruiting patients."
Answered by AI
What are the main goals that we hope to achieve with this experiment?
"The purpose of this study, which will take place over the course of 36 months, is to evaluate the efficacy of PVSRIPO in relation to Duration of Objective Radiographic Response. Additionally, safety data (in terms AEs) and disease control rate will be gathered, with comparisons made to an external control group."
Answered by AI
Has the FDA given thumbs up to PVSRIPO?
"While there is some evidence to support the safety of PVSRIPO, it scored a 2 because this is only a Phase 2 trial and thus there is no clinical data demonstrating its efficacy."
Answered by AI
At how many healthcare facilities is this research being conducted?
"This study is operational at 6 centres, 3 of which are in major metropolitan areas including Boston, San Francisco and Durham. The other locations may be less convenient to travel to, so it's best to select a trial site that is close by."
Answered by AI
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